Therapy Detail
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| Therapy Name | AU-011 |
| Synonyms | |
| Therapy Description |
AU-011 is a photodynamic therapy comprised of human papilloma virus derived nanoparticles conjugated to infrared dye, IR700, which upon irradiation results in reactive oxygen species generation and thus, subsequent cell death (Cancer Res 2014;74(19 Suppl):Abstract nr 1770, PMID: 30844944). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| AU-011 | Bel-sar|Belzupacap Sarotalocan | AU-011 is a photodynamic therapy comprised of human papilloma virus derived nanoparticles conjugated to infrared dye, IR700, which upon irradiation results in reactive oxygen species generation and thus, subsequent cell death (Cancer Res 2014;74(19 Suppl):Abstract nr 1770, PMID: 30844944). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05483868 | Phase I | AU-011 | A Phase 1, Open-label Trial of AU-011 (Belzupacap Sarotalocan) in NMIBC | Recruiting | USA | 0 |
| NCT04417530 | Phase II | AU-011 | Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation and Randomized, Masked Dose Expansion Designed to Evaluate Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma | Completed | USA | 0 |
| NCT06643884 | Phase II | AU-011 | Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors | Not yet recruiting | USA | 0 |
| NCT03052127 | Phase I | AU-011 | Phase 1B Study in Subjects With Small to Medium Primary Choroidal Melanoma | Completed | USA | 0 |
| NCT06007690 | Phase III | AU-011 | A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma (CoMpass) | Recruiting | USA | ISR | GBR | CAN | AUS | 0 |
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